The present invention generally relates to implantable medical devices (IMDs). Specifically, the invention pertains to an information network for remotely directing patient device data retrieval and device instruction updates. More specifically, the invention enables autonomous interrogation of the IMDs, without the intervention of an operator or a clinician, in real time. The collected data may be reviewed by a clinician or may be archived to compare patient history and for other future use. An interface medical unit or a programmer may be used to uplink the IMDs to the remote information network.
The present invention is compatible and complementary with the elements disclosed in the following pending applications: xe2x80x9cMedical System Having Improved Telemetry,xe2x80x9d filed Jul. 19, 1999, Ser. No. 09/356,340; xe2x80x9cSystem and Method for Transferring Information Relating to an Implantable Medical Device to a Remote Location,xe2x80x9d filed on Jul. 21, 1999, Ser. No. 09/358,081; xe2x80x9cApparatus and Method for Remote Troubleshooting, Maintenance and Upgrade of Implantable Device Systems,xe2x80x9d filed on Oct. 26, 1999, Ser. No. 09/426,741; xe2x80x9cTactile Feedback for Indicating Validity of Communication Link with an Implantable Medical Device,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/430,708; xe2x80x9cApparatus and Method for Automated Invoicing of Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/429; xe2x80x9cApparatus and Method for Remote Self-Identification of Components in Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/429,956; xe2x80x9cApparatus and Method to Automate Remote Software Updates of Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/429,960; xe2x80x9cMethod and Apparatus to Secure Data Transfer From Medical Device Systems,xe2x80x9d filed Nov. 2, 1999, Ser. No. 09/431,881 xe2x80x9cImplantable Medical Device Programming Apparatus Having An Auxiliary Component Storage Compartment,xe2x80x9d filed Nov. 4, 1999, Ser. No. 09/433,477; xe2x80x9cRemote Delivery Of Software-Based Training For Implantable Medical Device Systems,xe2x80x9d filed Nov. 10, 1999, Ser. No. 09/437,615; xe2x80x9cApparatus and Method for Remote Therapy and Diagnosis in Medical Devices Via Interface Systems,xe2x80x9d filed Dec. 14, 1999, Ser. No. 09/460,580; xe2x80x9cVirtual Remote Monitor, Alert, Diagnostics and Programming For Implantable Medical Device Systemsxe2x80x9d filed Dec. 17, 1999, Ser. No. 09/466,284; xe2x80x9cInstrumentation and Software for Remote Monitoring and Programming of Implantable Medical Devices (IMDs)xe2x80x9d, filed Dec. 21, 1999, Ser. No. 60/172,937; xe2x80x9cApplication Proxy For Telecommunication-enabled Remote Medical Access Instruments,xe2x80x9d filed Dec. 23, 1999, Ser. No, 60/173,081; xe2x80x9cInformation Network Scheme For Interrogation Of Implantable Medical Devices (IMDs),xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,064; xe2x80x9cMedical Device GUI For Cardiac Electrophysiology Display And Data Communications,xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,065; xe2x80x9cIntegrated Software System For Implantable Medical Device Installation And Management,xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,082; xe2x80x9cDynamic Bandwidth Monitor And Adjuster For Remote Communications With A Medical Device,xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,083 xe2x80x9cLarge-Scale Processing Loop For Implantable Medical Devices (IMDs),xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,079; xe2x80x9cChronic Real-Time Information Management Systems For Implantable Medical Devices (IMDs),xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,062; xe2x80x9cAutomatic Voice and Data Recognition For Medical Device Instrument Systems,xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,071 xe2x80x9cCentral Switchboard to Facilitate Remote Collaboration With Medical Instruments,xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,080; which are all incorporated by reference herein in their entireties.
In the traditional provision of any medical services, including routine check-ups and monitoring, a patient is required to physically present themselves at a provider""s office or other clinical setting. In emergency situations, health care providers may travel to a patient""s location, typically to provide stabilization during transport to a clinical setting, e.g., an emergency room. In some medical treatment applications, accepted medical practice for many procedures will naturally dictate physical proximity of medical providers and patients. However, the physical transport of patients to clinical settings requires logistical planning such as transportation, appointments, and dealing with cancellations and other scheduling complications. As a result of such logistical complications, patient compliance and clinician efficiency may suffer. In certain situations, delays caused by patient transport or scheduling may result in attendant delays in detection of medical conditions including life-threatening situations. It is desirable, therefore, to minimize situations in which the physical transport of a patient to a clinical setting is required. It may also be desirable to minimize the extent to which an patient or patient information must be considered by a clinician at a particular time, i.e. during an appointment.
After the implantation of an IMD, for example, a cardiac pacemaker, clinician involvement with respect to the IMD has typically only begun. The IMD usually cannot be merely implanted and forgotten, but must be monitored for optimal results, and may require occasional adjustment of certain parameters or settings, or even replacement, in response to or in anticipation of changes in patient condition or other environmental factors, or based on factors internal to the device. IMDs may also contain logic devices such as digital controllers, which may need to undergo firmware or software upgrades or modifications. In addition, information about the IMD may be gathered for treatment or research purposes. For example, many IMDs are capable of storing certain state information or other data regarding their operation internally in addition to physiological data.
Because IMD operation and patient physiology is preferably monitored to help effect the desired patient outcome, it would be desirable if data collected by an IMD could be viewed remotely. Similarly, it would also be desirable that the instructions installed in an IMD may be modified in response to patient physiologic information, or perhaps be upgraded remotely as well.
In the event a change, modification or reprogramming of the IMDs is indicated, it would be desireable if the instruction could be implemented in the IMD as soon as possible, thus providing more continuous monitoring to proactively effect changes in the IMDs for efficient therapy and clinical care. This scenario may be contrasted with existing practice of responding to an adverse patient event or subjecting the patient to the inconvenience or expense of frequent in-person encounters with a clinician, for example after an unexpected therapy by the device, or to effect other monitoring of device functioning, e.g., spontaneous therapies by the device. For example, an implanted cardioverter defibrillator may administer to the host patient a cardioversion or defibrillation therapy. After such therapy, it is typically desirable to determine the parameters of, for example, an arrhythmia that a therapy was administered in response to, or of the therapy administered.
Despite the limitations of IMDs with regard to processing power, IMDs are in a unique position to monitor physiological systems continuously. High-resolution data can be collected, but implantable devices are ill suited to storage and processing of large amounts of complex physiological data. In contrast, computing power and data storage capacity (processor capability, memory, and adequate power supply) is abundantly available in the non-implantable (xe2x80x9cexternalxe2x80x9d) world. The computing industry is still following Moore""s Law (stating that transistor density will double every 18 months), delivering increasingly sophisticated computing devices yearly, and some of these gains accrue to the computer power of IMDs. However, frequent upgrading and replacement of IMDs based on more powerful models subjects a patient to additional stresses, and additional costs are imposed on the patient or health care system.
Prior art methods of clinical services, particularly IMD monitoring and adjustment, are generally limited to in-hospital procedures or other scenarios involving patient transportation to a clinical setting. For example, if a physician needs to review the performance parameters of an IMD in a patient, it is likely that the patient has to go to the clinic. Further, if the medical conditions of a patient with an IMD warrant a continuous monitoring or adjustment of the device, the patient would have to stay in a hospital indefinitely. Such a continued treatment plan poses both economic and social problems. Under the prior art, as the segment of the population with IMDs increases, many more hospitals and clinics, and attendant clinicians and service personnel will be needed to provide in-hospital service for the patients, thus escalating the cost of healthcare. Additionally, the patients will be unduly restricted and inconvenienced by the need to either stay in the hospital or make very frequent visits to a clinic.
Yet another condition of the prior art practice requires that a patient visit a clinic center for occasional retrieval of data from the implanted device to assess the operations of the device and gather patient history for both clinical and research purposes. Such data is acquired by having the patient in a hospital/clinic to download the stored data from the IMD. Depending on the frequency of data collection, this procedure may pose serious difficulty and inconvenience for patients who live in rural areas or have limited mobility. Similarly, in the event a need arises to upgrade the software of an implantable medical device, the patient will be required to come into the clinic or hospital to have the upgrade installed.
Further, it is a typical medical practice keep an accurate record of past and contemporaneous procedures relating to an IMD uplink with, for example, an IMD programmer, i.e. a computer capable of making changes to the firmware or software of an IMD. It is typically desired that the report contain the identification of all the medical devices involved in any interactive procedure. Specifically, all peripheral and major devices that are used in downlinking to the IMD may be reported. Currently, such procedures are manually reported, and require an operator or a medical person to manually enter data during each procedure. One of the limitations of such manual reporting procedures is the possibility for human error in data entry, thus motivating rechecking of the data to verify accuracy. Generally, the use of human clinicians and technicians to analyze data and implement changes in device therapy can result in inefficiencies and errors.
Yet a further condition of the prior art relates to the interface between a human operator and a programmer system. To aid a patient in the administration of a deployed medical device, clinicians such as pacing clinicians may be made available to implement desirable changes in the treatment regimen effected by an IMD. Generally, a medical device manager/technician should be trained on the clinical and operational aspects of the programmer. Under current practices, a technician may attend a class or training session sponsored by a clinic, a hospital, or the manufacturer to successfully manage a programmer-IMD procedure. Further, ideally the operator will keep abreast of new developments and new procedures in the management, maintenance and upgrade of the IMD. Accordingly, it is desirable that operators of programmers, IMDs, and related medical devices receive regular training or information about the IMDs they work with. This information will preferably be widely distributed, because IMDs, programmer devices, and related medical devices are distributed throughout the world. Further, the number of people having implanted medical devices has been increasing over the last few years, with an attendant increase in operator personnel. The total effect of these phenomenon is a widely dispersed and large body of operators. Thus, it is desirable to have a high efficiency communications system that would enhance data communications, both between the IMDs and medical instruments, such as programmers; and between operators and entities providing IMD updates and education such as manufacturers. However, despite any improvement in clinician communication and training that may be effected, it may be desirable to automate device administration, maintenance, and upgrading to the extent possible in order to ensure that device instructions and data are appropriate to the situation.
A further limitation of the prior art relates to the management of multiple medical devices in a single patient. Advances in modern patient therapy and treatment have made it possible to implant a number of devices in a patient. For example, IMDs such as a defibrillator or a pacer, a neural implant, a drug pump, a separate physiologic monitor and various other IMDs may be implanted in a single patient. To successfully manage the operations and assess the performance of each device in a patient with multi-implants may require frequent update and monitoring of the devices.
Confirmation of basic device functioning following therapy events has been effected in the past using telephonic means. However, former methods of communication with medical devices did not provide for updating of software and firmware, or allow for operator training. In addition, former methods of communication with remote devices required the involvement of clinical personnel in the interpretation of data and prescription of treatment regimens or therapies. It would be desirable to remotely communicate information to and from implantable medical devices, and also provide for authentication of target device as well as confirmation of data integrity following the transmission of the patient data. Furthermore, it would be desirable to limit the degree to which human and particularly clinician involvement is required to effect the communication between an IMD and a remote resource.
Further, it may be preferred to have an operable communication between the various implants to provide a coordinated clinical therapy to the patient. Thus, there is a need to monitor the IMDs and the programmer on a regular, if not a continuous, basis to ensure optimal patient care. In the absence of other alternatives, this imposes a great burden on the patient if a hospital or clinic is the only center where the necessary upgrade, follow up, evaluation and adjustment of the IMDs could be made. Further, even if feasible, the situation would require the establishment of multiple service areas or clinic centers to support the burgeoning number of multi-implant patients worldwide.
The present invention provides a system for directing remote interrogation of IMDs implanted in patients, even when the patients are in a location remote from the interrogation equipment. In one embodiment, the invention may be used to reduce or eliminate the need for a clinician or other person available to administer device interrogation. The invention may also create a means for gathering device data in advance of its actual review of a clinician. A remote interrogation will preferably allow clinicians to review data intermittently, even while an IMD is still accessing or adding to the same body of data as stored in memory on-board the IMD. In one embodiment of the invention, a computer remote to the host patient may initiate and subsequently store the contents of IMD device memory interrogated and transmitted to the remote computer. This data would then be available for examination in the future. For example, a referring physician could use the ability to examine the patient remotely as a consultation system.
A technology-based health care system that fully integrates the technical and social aspects of patient care and therapy will preferably flawlessly connect the client with care providers irrespective of separation distance or location of the participants. Accordingly it is desirable to have a programmer unit that would connect to a centralized data source and repository. This may be termed, for example, a remote interrogator, or a remote data center. This remote data center will preferably provide access to an expert system allowing for downloading of upgrade data or other information to a local, i.e., IMD environment. Further, in one embodiment of the present invention, it is possible to enable the gathering of high resolution diagnostic/physiologic data, and to transfer information between the IMDs and a remote data center to dispense therapy and clinical care on real-time basis. Further, the data system contemplated by the present invention enables an efficient system for data storage, collection and processing to effect changes in control algorithms of the IMDs and associated medical units to promote real-time therapy and clinical care.
The proliferation of patients with multi-implant medical devices worldwide has made it imperative to provide remote services to the IMDs and timely clinical care to the patient. The use of programmers and related devices to communicate with the IMDs and provide various remote services has become an important aspect of patient care. In addition to the instant invention, the use of programmers may be implemented in a manner consistent with the co-pending applications detailed in the foregoing Cross Reference to Related Applications, and assigned to the assignee of the instant invention. In light of the disclosures of these incorporated references, the present invention provides a vital system and method of delivering efficient therapy and clinical care to the patient.
In a representative embodiment of the instant invention, one or more IMDs, such as a pacemaker, defibrillator, drug pump, neurological stimulator, physiological signal recorder may be deployed in a patient. The IMD may be equipped with a radio frequency transmitter or receiver, or an alternate wireless communication telemetry technique or media which may travel through human tissue. For example, the IMD may contain a transmission device capable of transmitting through human tissue such as radio frequency telemetry, acoustic telemetry, or a transmission technique that uses patient tissue as a transmission medium. Alternately, an IMD may be deployed in a configuration where a transmission or receiving device is visible externally to the patient but is connected directly or via wires to the IMD. An external device, which may generally be termed an IMD Network Interface (IMDNI), may be positioned outside the patient, the IMDNI being equipped with a radio frequency or other communication means compatible with the communication media of the IMD or the IMD transmitter/receiver, which may be external to the IMD and may further be external to the patient. In an illustrative embodiment of the subject invention, IMDNI contains a radio frequency transmitter/receiver or similar radio frequency telemetry device. Communication may be effected between the IMD transmitter/receiver and the external IMDNI, e.g. via radio frequency. The IMDNI will be connected via a wireless or physical communication media, e.g. via modem and direct dial connection, with a data network, LAN, WAN, wireless, or infrared network. In an alternate embodiment of the subject invention, the IMDNI may have a direct connection or tunneled connection directly to the centralized computing resource. In yet another alternate embodiment of the subject invention, the system may be implemented as a data network that allows the IMDNI access to the computing center from many locations, for example providing for a IMDNI that is portable.
Using the computing power of external computing devices, the monitoring of long-term disease progression (e.g. heart failure, hypertension, diabetes) can be improved. Furthermore, therapies may be adjusted with finer granularity and improved results, with reduced need for human intervention and reduced opportunity for clinician error.
In addition to improved modeling of physiologic systems, the amount of historical data, particularly patient-specific historical data used as input to control systems can be virtually unlimited when it is stored externally to the patient. Furthermore, a more thorough comparison can be made between patients with similar diseases as data and therapy direction are centralized, which may be expected to result in gains to the body of medical knowledge and treatment efficacy. Data from other medical systems, either implanted or external, such as etiological databases, can be incorporated easily into the control system. Other anonymous patient experiences or treatment data may be more quickly incorporated into a subject patient""s IMD regime than might be possible with existing systems of IMD programming or upgrading. In addition, a subject patient""s own historical treatment parameters and corresponding outcomes may be used in making IMD programming and other treatment decisions.
The instant invention provides IMDs with access to virtually unlimited computing power as part of their data collection and therapy calculation processes. In an alternate embodiment of the present invention, the IMD may be used by an external computing device as a data collection agent, and as an agent to implement changes to a treatment regimen based on a complex dynamical or stochastic physiological model. Rather than continuously increasing the processing power of IMDs, the present invention provides a link with external computing power, which is more easily upgraded. In addition, control system algorithms based on current knowledge about physiologic systems could be more easily updated using a centralized powerful processor, rather than individually updating the firmware or software of thousands of deployed IMDs.
When multiple IMDs are deployed within a single patient, the data and therapy from these IMDs may be more easily and efficiently orchestrated, thus further improving treatment efficacy and convenience to the patient and clinician, and in some cases judiciously limiting clinician involvement. In addition, high resolution or finely grained data may be collected and stored from a vast number of subject IMDs. This finely grained patient data may be expected to prove valuable in defining and modifying an individual patient""s treatment regimen as implemented by an IMD. In addition, this high-resolution data may be analyzed on a mass scale, providing opportunities for improvement of existing physiologic models. This data may serve, for example, to validate physiologic models being employed, or may suggest refinement of these models based on numerous patient outcomes.
This refinement of therapy and diagnostic algorithms or models may further be refined in conjunction with external medical devices as well. According to the present invention, IMD management and manipulation will be more efficient and efficacious. For example, an embodiment of the present invention permits the use of complex control systems to manage therapy of implantable medical devices. In addition, the invention permits the orchestration of the data collection and therapy functions of IMDs, particularly the functions of multiple IMDs implanted in one patient. In addition, an embodiment of the present invention permits of centralized therapy prescription, and provides the ability to compare disease states, diagnostic data and therapy prescription across patients with fine granularity. The ability to update control system software and hardware at a central location is also provided, as well as the ability to upgrade the firmware or software in distributed deployed IMDs from one central location.
A communications system according to the present invention provides the ability to have high-power computing systems interact with implanted medical devices, thus providing the ability to use complex control algorithms and models in implanted medical devices. In addition, even with relatively simple modeling, or in stochastic models, relatively large amounts of historical data from a single or multiple medical devices may be brought to bear for predictive purposes in evaluating alternate therapy and IMD instruction prescriptions. The present invention provides a system that establishes an external communications device and data network as a xe2x80x98data busxe2x80x99 for extending the processing power of deployed IMDs, while minimizing host patient and clinician inconvenience.
The present invention may be effected, in part, by the provision of an IMDNI device, which may be a standalone device or a computer peripheral device, that is capable of connecting an IMD, or simply data telemetrically received from an IMD, to a network or other data communication link. While the interface between a computer data link and an implanted medical device is referred to generally herein as a xe2x80x9cNetwork Interfacexe2x80x9d, or the like, it will be appreciated to those skilled in the art that the interface may serve as an interface to a variety of data communications systems, including not only networks, but also, without limitation, direct dial-up connections, dedicated lines, direct satellite links, and other non-network data communications connections.
In a preferred embodiment of the subject invention, a host patient, i.e., a patient having an IMD implanted within, presents themselves to a IMD network interface device, or IMDNI. This IMDNI will preferably have the capability of communicating with the IMD via wireless means, such as by radio transmissions. In one embodiment of the subject invention, the IMDNI may be placed, for example, in a patient""s home, or may be available for use by several patients in a treatment facility such as a hospital, nursing home, or ambulatory care center.
In one embodiment of the invention, data can be interrogated, with the aid of a remote interrogator device, by an IMDNI in an emergency room and then uploaded to an information network to which a remote interrogator is connected. This information network may be according to any network protocol, for example, TCP/IP over the Internet. The uploading to a central interrogation computer may also be effected over a direct dial-up connection or a dedicated line. Upon uploading of the data, a medical professional or other clinician may be alerted to the fact the data has been uploaded. This clinician may then view the data. A patient could also interrogate his or her device at home and upload it for a medical professional or clinician to view later. Various scenarios according to the invention may provide convenient monitoring of IMD functioning to a host patient or clinician. For example, a patient may effect a test of their IMD with a device tests such as an exercise or stress test in a more natural or real life scenario that may provide more reliable or accurate results than a clinical evaluation, in addition to providing increased convenience to the patient and reducing the need for clinician or other professional attention.
In this embodiment of the invention, for example, a host patient may effect a dial-up connection to a remote interrogator following an afternoon walk in their neighborhood or on a treadmill in their home. In addition to evaluation of device function during routine situations, according to this embodiment of the present invention, a home monitoring instrument may be provided to a host patient allowing the patient to send data, i.e., to effect remote interrogation, if, for example, they have a subjective belief that they are symptomatic. For example, a host patient of a cardioverter defibrillator IMD may effect remote interrogation if they believe they have suffered an arrhythmia event. The data resulting from the remote interrogation may then be made remotely accessible for evaluation by a pacing system expert. In a preferred embodiment of the subject invention, IMD function data and physiologic data of the host patient is made available nearly instantaneously to a clinician capable of evaluating the device function, physiologic event or data, or therapy administered by the target IMD.
In a preferred embodiment, the remote interrogator of the present invention is implemented as a software application which may be run on a server or central computer accessible via a network or direct connection by the IMDNI device. In an alternate embodiment, the IMDNI may be implemented as a software client which may run on a computer remotely from the interrogator server. Preferably, the remote interrogator program or device is capable of autonomously and dynamically determining the model of an IMD, for example, according to manufacturer, type, and model number, as well as the specific serial number of a particular device. When an IMD is within communication range of an IMDNI, the remote interrogator of the present invention is also preferably capable of configuring a deployed IMD, or commanding the IMDNI to retrieve data from the IMD.
In a preferred embodiment, an interaction between a deployed IMD and the remote interrogator may take place within a discrete session. This session may encompass interrogation of one or more IMDs deployed in a single patient. In a representative embodiment, a session according to the present invention may proceed according to the following scenario. In order to begin an interrogation session, a host patient will typically present to an IMDNI. For example, the patient may place themselves in the vicinity of the IMDNI within range of the telemetry capacities of the IMDNI. This may take place at home in the case of a In Home Monitor (IHM) or at a medical facility such as an Emergency Room, Follow-up Clinic or Operating Room. At the initiation of a session, it will be preferable to configure the target IMD for optimal operation for remote interrogation. For example, the IMDNI may be programmed to issue a command to the target IMD to xe2x80x9cCancel Magnetxe2x80x9d, xe2x80x9cResume Therapy,xe2x80x9d or another command to enter a mode consistent with the interrogation process. Either prior to or after the establishment of a telemetry or other communication link with the target IMD, the IMDNI Operator will effect a communications link between the IMDNI and the remote interrogation computer. This IMDNI Operator may be a human attendant or technician, but preferably will be an automated module of the IMDNI firmware or software, or may be implemented as a software application on a general purpose computer connected to the IMDNI. Alternatively, the remote interrogator computer may lead a human or automated IMDNI through the steps of establishing a telemetry interface between the IMD and IMDNI; with the IMDNI in turn notifying the remote interrogator when a telemetry connection has been established. Communication with the remote interrogation server may be established via a network connection, such as a LAN or WAN. In this embodiment of the present invention in which the IMDNI is preferably attended by an operator, the operator may be the host patient of the target IMD, or it may be attendant personnel at a clinical setting. In either case, the operator may connect the IMDNI to a suitable network connection, if a network connection is not already in place. For example, a direct dial-up connection may be established in this manner by physically connecting the IMDNI into a telephone connection jack such as a RJ-11 analog jack. The operator at some point would turn the IMDNI on and cause the IMDNI system to dial a pre-configured telephone number. Alternately, other, more continuous types of network connections may also be established.